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BD (Becton, Dickinson and Company) Staff Product Engineer, Test Method Development (Hybrid) in Franklin Lakes, New Jersey

Job Description Summary

Staff Test Method Development and Validation Engineer

Job Description

We are the makers of possible

BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.

We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us.

Within our CC/IS/IPS (Catheter Care Injection Systems and Infusion Preparation Disposables) business, the Medication Delivery R&D team is seeking a S taff Product Engineer, to join us. In this exciting role, you will impact health care by driving commercialization of new products and design changes for current products through all phases. You will use your experience and expertise to plan, design, build, and qualify measurement systems and methods vital to the evaluation of product safety, efficacy, performance, and compliance while ensuring accurate completion of project and business goals. You will develop and drive the strategy and execution of product design verification and validation activities to demonstrate product safety, efficacy, performance, and compliance. You will support the development of the product designs and associated requirements to efficiently demonstrate their safety and efficacy.

Duties & Responsibilities

  • This role will provide subject matterexpertise(SME) in the areas of:

  • Mechanical and analytical testing development and methodologies for medical devices, materials, and combination products.

  • Including leading and supporting routine and non-routine USP, ASTM, ISO,and product performance and function testing.

  • Develop test methods and craft requirements in the subject matter area which follow innovative and industry practices and standards not limited to USP, ASTM, and ISO.

  • Apply rigorous and innovative approaches for developmentof test methods fornovel and non-compendial product evaluations.

  • Understand and proliferate standard methodologies asit relates to testing

  • Be versed in statistical analysis of method outputs, sample sizes related to and used in method validation and design verification.

  • Plan and support through all project phases, with a focus on the strategy and execution of measurement system development/qualification, design verification and design validation.

  • Independently support product development projects and effectively define problems, collect, and interpret data, establish facts, draw valid scientific conclusions, and propose solutions or corrective actions.

  • Craft, edit, and interpret technical drawings and technical reports and write protocols, reports, work instructions, presentations, etc.

  • Expertly apply engineering principles for design/analysis and complete statistical analysis and sample plan development.

  • Demonstrate accountability for the successful and timely achievement of goals.

  • Present to peer and customer audience on area of expertise to empower the organization and disseminate data and conclusions.

Education & Experience

  • Bachelor's degree with a minimum of 10+ years of experience in medical device or other regulated industry OR Master's degree in Mechanical or Biomedical Engineering and 5+ years of experience OR PhD in Mechanical or Biomedical Engineering and 3+ years of experience.

  • Expertisewith test method development, validation strategy, and execution is required.

  • Expertise with design verification & validation strategy development and execution is required.

  • Strong track record of technical problem solving and effective product development through expert application of engineering principles is required.

  • Design controls expertise

  • Experience with traditional and modern fabrication techniques is required.

  • Experience in packaging testing methodologies and industry standards is a plus

  • Experience in solid modeling (SolidWorks) or electromechanical systems is a plus.

  • Experience in high-volume manufacturing processes is a plus.

  • Experience developing and commercializing medical devices is a plus

  • Exposure to Chemistry/ Chemical Engineering and/or structural analysis and simulation/mathematical modeling desirable.

  • DFSS training or certifications are a plus.

Knowledge, Skills & Abilities

  • Ability to lead and teach others to assess project/program needs, formulate strategy, build support, and implement initiatives.

  • Strong interpersonal and decision-making skills and the ability to effectively manage change and uncertainty.

  • Ability to engage and mentor team members and to maximize diverse perspectives to achieve the best outcomes.

We offer a comprehensive Total Rewards program aimed at the varying needs of our diverse and global associates. The sum of our programs and policies, which includes pay, benefits, recognition, life balance, career, and community components, is one of the many reasons people choose to work at BD.

For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.

Why Join Us?

A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It’s also a place where we help each other be great, we do what’s right, we hold each other accountable, and learn and improve every day.

To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you’ll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place.

To learn more about BD visit  https://bd.com/careers

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

PDN

Primary Work Location

USA NJ - Franklin Lakes

Additional Locations

Work Shift

NA (United States of America)

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

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